CN102256660B - 用于组织标记物放置的标记物输送装置 - Google Patents
用于组织标记物放置的标记物输送装置 Download PDFInfo
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Abstract
一种标记物输送装置被配置用于部署组织标记物。所述标记物输送装置包括具有室的手柄,和套管。根据一个方面,所述套管具有由狭槽阵列形成的挠性部分,所述狭槽阵列具有通过套管的侧壁延伸到内腔的多个基本间隔开的平行外周狭槽。标记物引入器杆能移动地布置在套管的内腔中以便部署标记物,并且具有对应于套管的挠性部分的挠性区域。根据另一个方面,回缩机构安装到手柄并且被配置为当致动回缩机构时便于套管和标记物引入器杆都完全回缩到手柄的外壳的室中。
Description
技术领域
本发明涉及医疗装置,尤其涉及用于经皮组织标记物放置的标记物输送装置。
背景技术
在希望确定待活检的病变或其他组织是否癌变的情况下通常对人体的许多区域和器官执行组织活检。通常,通过诸如计算机轴向断层(CAT)扫描、超声波扫描和乳房X线照相术的成像技术的使用来识别待活检的病变或其他组织。
例如在乳房活检中,病变典型地太小使得活检将它的尺寸减小到通过所应用的成像方法不再可见的程度。在受影响的组织的完全去除被指示的情况下,希望在活检的部位放置组织标记物以允许医师随后快速和准确地定位病变。组织标记物例如由标记物输送装置放置在活检部位,所述标记物输送装置具有容纳组织标记物的针套管。
在一些标记物输送装置中,标记物可能不完全从套管弹出,或者可能由在缩回套管时产生的真空拉回套管中或朝着套管被拉回,这导致标记物从预期部位移动,导致活检区域的位置的不准确识别。另一个问题是使用后标记物输送装置的安全处置,特别是被插入患者的组织中、典型地具有尖锐尖端的标记物输送装置的套管部分的安全处置。
发明内容
根据本发明的一个方面,本发明提供了一种标记物输送装置,其被配置为在患者中的输送部位完全输送组织标记物,在所述输送部位组织标记物不太可能迁移,这通过经由刚性套管输送组织标记物实现,所述刚性套管具有用于将套管的远端引导到例如邻近活检部位的组织中的挠性部分。根据本发明的另一个方面,本发明提供了一种标记物输送装置,其被配置为便于使用后标记物输送装置的安全处置。所述标记物输送装置例如可以与诸如X射线、超声、MRI等的各种成像系统联合使用。
本发明在它的一个形式中涉及一种被配置用于部署组织标记物的标记物输送装置。所述被配置用于部署组织标记物的标记物输送装置包括:具有室的手柄;套管,其被配置用于保持所述组织标记物以使部署,所述套管具有围绕内腔的侧壁,所述内腔沿着所述套管的纵向范围延伸,所述套管具有由狭槽阵列形成的挠性部分,所述狭槽阵列具有通过所述套管的所述侧壁延伸到所述内腔的多个外周狭槽,所述多个外周狭槽被间隔开以沿着所述套管的纵向范围基本平行,从而便于在所述套管的所述挠性部分处的挠曲;标记物引入器杆,其能移动地布置在所述套管的所述内腔中,所述标记物引入器杆具有对应于所述套管的所述挠性部分的挠性区域;部署机构,其安装到所述手柄并且被配置为当致动所述部署机构时使所述标记物引入器杆移位以部署所述组织标记物,以及回缩机构,其安装到所述手柄并且被配置为当致动所述回缩机构时便于所述套管和所述标记物引入器杆都完全回缩到所述手柄的外壳的所述室中。
本发明在它的另一个形式中涉及一种被配置用于部署组织标记物的标记物输送装置,包括:手柄,其被配置为由用户抓握;套管,其具有近端和远端,所述近端联接到所述手柄,所述套管是基本刚性的并且具有围绕内腔的侧壁,所述内腔沿着所述套管的纵向范围延伸,所述套管具有由狭槽阵列形成的挠性部分,所述狭槽阵列具有通过所述套管的所述侧壁延伸到所述内腔的多个外周狭槽,所述多个外周狭槽被间隔开以沿着所述套管的纵向范围基本平行,从而便于在所述套管的所述挠性部分处的挠曲;以及标记物引入器杆,其能移动地布置在所述套管的所述内腔中以实现从所述套管的所述远端部署所述组织标记物,所述标记物引入器杆具有致动端和标记物部署端,以及对应于所述套管的所述挠性部分的挠性区域。
本发明在它的另一个形式中涉及一种被配置用于部署组织标记物的标记物输送装置,包括:手柄,其被配置为由用户抓握,所述手柄包括外壳,所述外壳具有前端和后端以及位于所述前端和所述后端之间的室,并且所述外壳具有从所述室通向所述手柄的外部的孔;套管,其具有近端、远端和沿着所述套管的纵向范围在所述近端和所述远端之间延伸的内腔,所述套管定位在所述手柄中使得所述套管通过所述孔能回缩地延伸超出所述外壳的前端;标记物引入器杆,其能移动地布置在所述套管的所述内腔中以实现从所述套管的远端部署所述组织标记物,所述标记物引入器杆具有致动端和标记物部署端;安装到所述外壳的部署机构,所述部署机构联接到所述标记物引入器杆的所述致动端,所述部署机构被配置为当致动所述部署机构时使所述标记物引入器杆移位以部署所述组织标记物,以及安装到所述外壳的回缩机构,所述回缩机构联接到所述套管的近端,所述回缩机构被配置为当致动所述回缩机构时便于所述套管和所述标记物引入器杆都完全回缩到所述手柄的所述外壳的所述室中。
附图说明
通过参考结合附图进行的本发明的实施例的以下描述将更显而易见本发明的上述和其他特征和优点,以及实现它们的方式,在附图中:
图1是根据本发明的一个实施例的被配置用于部署组织标记物的标记物输送装置的透视图;
图2是沿着平面2-2获得的图1的标记物输送装置的一部分的截面图;
图3是沿着平面3-3获得的图1的标记物输送装置的一部分的截面图;
图4A是图1的标记物输送装置的套管的一部分的顶视图,显示了套管的挠性部分;
图4B是图4A的套管的挠性部分的侧视图,以虚线显示了套管的挠性部分相对于非挠曲部分的挠曲;
图4C是从在套管的远端看向套管的内腔的视角的图4A的套管的端视图,也以虚线显示了套管的挠性部分相对于非挠曲部分的挠曲;
图5是图1的标记物输送装置的挠性部分的一个备选配置的顶视图;
图6是图1的标记物输送装置的套管的挠性部分的另一个备选配置的顶视图;
图7是图1的标记物输送装置的标记物引入器杆的一部分的侧视图,显示了致动端、标记物部署端和挠性区域;
图8是结合活检装置使用的图1的标记物输送装置的透视图,显示了套管的挠性部分的挠曲;
图9是在套管和标记物引入器杆完全回缩到手柄的外壳的纵向室中之后图1的标记物输送装置的透视图;
图10是根据本发明的另一个实施例的被配置用于部署组织标记物的标记物输送装置的透视图;
图11是沿着平面11-11的图10的标记物输送装置的截面图,显示了处于初始位置的部署机构;
图12是图10的标记物输送装置的截面图,显示了处于标记物部署位置的部署机构;
图13是图10的标记物输送装置的截面图,显示了处于标记物引入器杆初始回缩位置的部署机构;
图14是图10的标记物输送装置的截面图,显示了处于标记物引入器杆初始回缩后位置的部署机构;以及
图15是沿着平面15-15获得的图10的标记物输送装置的一部分的截面图,显示了套管回缩机构。
在若干视图中相应的附图标记始终表示相应的部分。本文中阐述的范例举例说明了本发明的实施例,并且这样的范例不应当被理解为以任何方式限制本发明的范围。
具体实施方式
现在参考附图,尤其参考图1-3,显示了根据本发明的一个实施例的被配置用于部署组织标记物12的标记物输送装置10。
标记物输送装置10包括手柄14,套管16,标记物引入器杆18部署机构20和回缩机构22。
手柄14被配置为由用户抓握,即,具有适当的尺寸和形状以由标记物输送装置10的用户的手抓握。手柄14包括外壳24,所述外壳具有前端24-1,后端24-2和侧壁24-3,以及位于前端24-1和后端24-2之间由侧壁24-3围绕的纵向室26。孔24-4通过外壳24的前端24-1从室26通向手柄14的外部。触发器狭槽24-5延伸通过外壳24的侧壁24-3。
套管16被配置用于保持组织标记物12以用于部署到患者的组织块中,并且可以采用空心针的形式。在标记物部署之前套管16定位在手柄14中使得套管16通过孔24-4延伸超出外壳24的前端24-1。套管16具有近端16-1和远端16-2,其中近端16-1联接到手柄14。套管16具有围绕内腔16-4的侧壁16-3,所述内腔沿着套管16的纵轴16-5沿着纵向范围28延伸。套管16是基本刚性的,并且例如可以由金属材料制造,例如不锈钢、镍钛诺、镍铬合金、钛等。
也参考图4A-4C,套管16具有由狭槽阵列32形成的挠性部分30,所述狭槽阵列具有围绕套管16周向布置的多个外周狭槽34。狭槽阵列32例如可以通过在套管16中制造切口而形成于套管16中,例如通过使用切割激光器在套管中制造切口。在本实施例中,套管16的挠性部分30离套管16的远端16-2比离套管16的近端16-1更近。多个外周狭槽34通过套管16的侧壁16-2延伸到内腔16-4。而且,如图4C中所示,在本实施例中,狭槽阵列32的多个外周狭槽34的每个狭槽的周向范围34-1大约为套管16的总圆周的三分之二。
如图4A和4B中所示,在本实施例中多个外周狭槽34彼此被间隔开以沿着套管16的纵向范围28基本平行,从而便于在套管16的挠性部分30处的挠曲。图4B以虚线显示了套管16的挠性部分30相对于套管16的非挠曲部分的挠曲。如图4B和4C中所示,多个外周狭槽34的配置(例如狭槽沿着套管16的周向放置)可以被选择使得挠曲沿着单一预定平面36发生。在本实施例中,例如,基本平行的多个外周狭槽34的每一个外周狭槽被布置为正交于套管16的纵轴16-5。
多个外周狭槽34的配置和形成套管16的材料可以被选择使得挠曲不会导致套管16的永久变形。例如,可以通过实验研究和/或通过材料分析来选择狭槽的相对于纵轴16-5的狭槽宽度34-2,狭槽的周向范围34-1,狭槽沿着套管16的轴向放置,和用于形成套管16的材料,使得当套管16的远端16-2由外力(F)作用时由狭槽阵列32形成的挠性部分30将挠曲(例如相对于纵轴16-5成锐角弯曲),并且然后当外力(F)被去除时返回到偏转前状态,例如沿着纵轴16-5是直的。
图5显示了可以用作图4A-4C中所示的狭槽阵列32的一个替换选择的另一个狭槽阵列38。狭槽阵列38例如可以通过在套管16中制造切口而形成于套管16中,例如通过使用切割激光器在套管中制造切口。狭槽阵列38包括围绕套管16周向布置的多个外周狭槽40。多个外周狭槽40包括具有第一周向范围44-1的第一组外周狭槽42-1和具有第二周向范围44-2的第二组外周狭槽42-2。第一组外周狭槽42-1的第一周向范围44-1相对于第二组外周狭槽42-2的第二周向范围44-2在周向上错开。
图6显示了可以用作图4A-4C中所示的狭槽阵列32的另一个替换选择的另一个狭槽阵列46,所述另一个狭槽布置包括围绕套管16周向布置的多个外周狭槽34,但是另外包括轴向狭槽48,所述轴向狭槽沿着套管16的纵向范围28延伸以连接处于连续狭槽阵列中的多个外周狭槽34的至少一部分或全部。狭槽阵列46例如可以通过在套管16中制造切口而形成于套管16中,例如通过使用切割激光器在套管中制造切口。
再次参考图2和3,标记物引入器杆18可移动地布置在套管16的内腔16-4中以实现组织标记物12从套管16的远端16-2的部署。也参考图7,标记物引入器杆18具有致动端18-1和标记物部署端18-2,并且具有对应于套管16的挠性部分30的挠性区域50。因此,当套管16的挠性部分30挠曲时,挠性区域50也挠曲,同时保持标记物引入器杆18沿着内腔16-4纵向移动的能力以实现组织标记物12的部署。
标记物引入器杆18的挠性区域50可以形成为挠性金属元件或挠性塑料元件,在本实施例中可以相对于标记物引入器杆18的剩余部分的直径具有减小的直径。而且,标记物引入器杆18的剩余部分可以由金属或塑料形成。
图8示出了标记物输送装置10的一个关于套管16的挠性部分30的示例性实现方式,尤其显示了驱动器(未显示)被去除的示例性乳房活检装置52的一部分,所述驱动器驱动切割器和真空单元通过活检针54收割组织样本。其后,通过活检针54的内腔插入标记物输送装置10的套管16以用于将组织标记物12放置到患者的组织中。
活检针54具有侧面样本槽56,所述侧面样本槽通向位于活检针54的内腔处的样本室58。当套管16在活检针54的内腔中被推进到样本室58的末端时,在样本室58的末端处的斜坡表面58-1施加作用力(F)以偏转套管16的远端16-2,导致套管的挠性部分30的挠曲(也参见图4A-4C),由此使套管16的远端16-2暴露于样本槽56。随着套管16在活检针54的内腔中的进一步推进,如图8中所示,套管16的远端16-2通过样本槽56延伸以穿刺邻近活检部位的组织。
其后,标记物引入器杆18在套管16的内腔16-4中的推进(例如参见图3)导致组织标记物12被部署到围绕活检部位的组织中。在套管16的挠性部分30挠曲之前、期间和之后标记物引入器杆18的挠性区域50(例如参见图7)顺应套管16的挠性部分30的形状。
备选地,套管16的远端16-2可以暴露于样本槽56而不延伸通过样本槽56,并且组织标记物12可以通过活检针54的样本槽56部署到活检腔中。
再次参考图1-3,部署机构20安装到手柄14的外壳24并且被配置为当部署机构20由用户致动时移位标记物引入器杆18以用于部署组织标记物12。通常,部署机构20被配置为将标记物输送装置10限制为标记物部署的一次性使用。图1和2显示了处于初始位置60的部署机构20(标记物未被部署)并且图3显示了处于标记物部署位置62的部署机构20。
更具体地,部署机构20包括引入器杆导向块64,标记物部署触发器66,和第一剪切元件68。引入器杆导向块64例如通过将标记物引入器杆18的一部分模制到引入器杆导向块64中而固定地附连到标记物引入器杆18的致动端18-1,并且所述引入器杆导向块杆导向块可滑动地布置在外壳24的室26中。标记物部署触发器66可以在手柄14的外壳24的外部接近。标记物部署触发器66安装到外壳24以用于沿着外壳24的触发器狭槽24-5从图1和2中所示的初始位置60朝着外壳24的前端24-1滑动移动以将部署机构20定位在标记物部署位置62。
在本实施例中,标记物部署触发器66和引入器杆导向块64由第一剪切元件68连接。第一剪切元件68从标记物部署触发器66延伸并且在位于引入器杆导向块64中的凹窝70中。因此,标记物部署触发器66的致动导致第一剪切元件68移位引入器杆导向块64,引入器杆导向块又沿着套管16的纵向范围28移位标记物引入器杆18以从套管16的内腔16-4部署组织标记物12。第一剪切元件68具有横截面尺寸减小的区域68-1(例如环形凹槽)以提供剪切位置。
引入器杆导向块64的外部轮廓可以被选择以可滑动地接收在手柄14的外壳24的纵向室26的类似内部轮廓中。因此,在引入器杆导向块64的外部轮廓和纵向室26的类似内部轮廓为非圆形的实施例中,引入器杆导向块64防止标记物引入器杆18相对于手柄14的外壳24的旋转,因此保持标记物引入器杆18相对于手柄14的恒定取向。
而且,在引入器杆导向块64的外部轮廓和纵向室26的类似内部轮廓为圆形的实施例中,引入器杆导向块64的凹窝70可以采用周向凹槽的形式以便于标记物引入器杆18相对于手柄14的外壳24的角位置的变化(即,旋转)。在这样的情况下,定位在手柄14的外部的旋转器,例如旋钮(未显示),可以联接到引入器杆导向块64以实现标记物引入器杆18相对于手柄14的取向的变化。
如图2中最佳地所示,部署机构20还可以包括锁定机构72以在组织标记物12被部署之后将标记物部署触发器66锁定在标记物部署位置62。在本实施例中,锁定机构72包括形成于标记物部署触发器66上或附连到该标记物部署触发器的第一锁定元件72-1并且包括形成于外壳24上或附连到该外壳的第二锁定元件72-2。在操作中,当标记物部署触发器66定位在标记物部署位置62中时第一锁定元件72-1永久地接合第二锁定元件72-2,由此将标记物输送装置10限制一次性标记物部署操作。
第一锁定元件72-1和第二锁定元件72-2中的一个例如可以是锁定通道并且第一锁定元件72-1和第二锁定元件72-2中的另一个可以是弹簧加载插入元件,当标记物部署触发器66和标记物引入器杆18依次定位在标记物部署位置62中时所述弹簧加载插入元件接合锁定通道。在图2所示的本实施例中,例如,第一锁定元件72-1形成为标记物部署触发器66中的锁定通道,并且第二锁定元件72-2采用弹簧加载销的形式,当标记物部署触发器66朝着外壳24的前端24-1滑动以将部署机构20和将标记物引入器杆18依次定位在标记物部署位置62中时所述弹簧加载销接合锁定通道。作为另一个例子,当第二锁定元件72-2形成为外壳24中的锁定通道时,锁定通道可以由触发器狭槽24-5形成或与它一体化,并且作为弹簧加载插入元件的第一锁定元件72-1可以是具有突出部的悬臂,当标记物部署触发器66定位在标记物部署位置62中时所述突出部接合锁定通道。
再次参考图1-3,回缩机构22安装到手柄14的外壳24并且被配置为当回缩机构22由用户致动时便于套管16和标记物引入器杆18都完全回缩到手柄14的外壳24的室26中,这将最有可能在部署组织标记物12之后发生。回缩机构22被配置为在套管16和标记物引入器杆18完全回缩到室26中之后防止套管16和标记物引入器杆18延伸到手柄14的外壳24的室26之外,因此便于标记物输送装置10的安全处置,并且减少在标记物输送装置10的使用后对医务人员或患者的意外扎针的忧虑。
更具体地,回缩机构22包括回缩触发器74,套管导向块76,第二剪切元件78,和弹簧80。回缩触发器74可以采用例如通过侧壁24-3中的孔24-7在外壳24的外部可接近的按钮的形式。套管导向块76例如通过将套管16的一部分模制到套管导向块76中而固定地附连到套管16的近端16-1。套管导向块76可滑动地布置在外壳24的纵向室26中。在本实施例中,第二剪切元件78形成为回缩触发器74的延伸部。
如图3中最佳地所示,回缩触发器74和套管导向块76由驻留在位于套管导向块76中的凹窝82中的第二剪切元件78连接,因此保持套管导向块76相对于手柄14的外壳24固定,例如轴向固定。弹簧80位于外壳24的前端24-1和套管导向块76之间,其中在回缩触发器74的致动之前弹簧80处于压缩状态,因此提供作用于套管导向块76的预负荷。
套管导向块76的外部轮廓可以被选择以可滑动地接纳在手柄14的外壳24的纵向室26的类似内部轮廓中。因此,在套管导向块76的外部轮廓和纵向室26的类似内部轮廓为非圆形的实施例中,套管导向块76防止套管16相对于手柄14的外壳24的旋转,因此保持套管16相对于手柄14的恒定取向。
然而,在套管导向块76的外部轮廓和纵向室26的类似内部轮廓为圆形的实施例中,套管导向块76的凹窝82可以采用周向凹槽的形式以便于套管16相对于手柄14的外壳24的角位置的变化(即,旋转),因此便于套管16相对于手柄14的可变化取向。在这样的情况下,可以通过抓握套管16并且转动来手动地旋转套管16。备选地,定位在手柄14的外部的旋转器,例如旋钮(未显示),可以联接到导向块76以实现套管16相对于手柄14的取向的变化。
回缩触发器74的致动导致套管16和标记物引入器杆18都完全回缩到手柄14的外壳24的室26中。更具体地,如图3中所示,第二剪切元件78具有横截面尺寸减小的区域78-1(例如环形凹槽)以提供剪切位置。初始地,第二剪切元件78的横截面尺寸减小的区域78-1包含在形成于侧壁24-3中的孔24-7内,由此在横截面尺寸减小的区域78-1提供附加支撑。
在本实施例中,回缩触发器74的致动(按压)径向地移位第二剪切元件78,导致第二剪切元件78剪切。更具体地,通过按压回缩触发器74,第二剪切元件78的横截面尺寸减小的区域78-1通过外壳24的侧壁24-3进入纵向室26,使得第二剪切元件78的横截面尺寸减小的区域78-1不再由侧壁24-3支撑,并且由此由弹簧80施加的弹簧力克服第二剪切元件78的横截面尺寸减小的区域78-1的剪切阻力。第二剪切元件78的剪切导致弹簧80从图1-3中所示的压缩状态释放以迫使套管导向块76朝着外壳24的后端24-2移动以便开始套管16的初始回缩,并且其中弹簧80的继续解压缩导致套管导向块76撞击引入器杆导向块64以剪切第一剪切元件68,由此开始套管16和标记物引入器杆18同时回缩到手柄14的外壳24的室26中。套管16和标记物引入器杆18到手柄14中的同时回缩在套管16和标记物引入器杆18都完全包含在手柄14的外壳24的纵向室26中之后结束,如图9中所示。
备选地,间隔装置84(参见图1)可以定位在引入器杆导向块64和套管导向块76之间。间隔装置84具有沿着纵向范围28的长度使得当引入器杆导向块64定位在标记物部署位置62中时套管导向块76与引入器杆导向块64可操作地接触,从而当回缩触发器74移位时第一剪切元件68和第二剪切元件78基本同时被剪切,导致套管16和标记物引入器杆18同时完全回缩到外壳24的室26中。
图10-15显示了本发明的另一个实施例,显示了标记物输送装置110,其包括手柄112,套管16,标记物引入器杆18,部署机构114和套管回缩机构116。套管16和标记物引入器杆18可以如先前所述地被配置,并且因此为了简便起见这里将不重复它们的操作的全部细节。标记物输送装置110与标记物输送装置10的实施例在功能上的区别在于标记物输送装置110的部署机构114可以被配置为在开始由套管回缩机构116实现的套管16的回缩之前便于标记物引入器杆18的完全回缩。
手柄112被配置为具有适当的尺寸和形状以由标记物输送装置110的用户的手抓握。手柄112包括外壳118,所述外壳具有前端118-1,后端118-2和侧壁118-3,以及位于前端118-1和后端118-2之间由侧壁118-3围绕的纵向室120。孔118-4通过外壳118的前端118-1从纵向室120通向手柄112的外部。套管16定位在手柄112中使得在标记物部署之前套管16初始通过孔118-4延伸超出外壳118的前端118-1。触发器狭槽118-5延伸通过外壳118的侧壁118-3。
部署机构114安装到手柄112的外壳118并且被配置为当部署机构114由用户致动时移位标记物引入器杆18以用于部署组织标记物12。图10和11显示了处于初始位置121的部署机构114(未使用,标记物未被部署),图12显示了处于标记物部署位置122的部署机构114,图13显示了处于标记物引入器杆初始回缩位置124的部署机构114,并且图14显示了处于标记物引入器杆初始回缩后位置126的部署机构114。
部署机构114包括引入器杆导向块128,多级标记物部署触发器130,第一剪切元件132,和引入器杆回缩弹簧133。第一剪切元件132具有横截面尺寸减小的区域132-1(例如环形凹槽)以提供剪切位置。引入器杆导向块128附连到标记物引入器杆18的致动端18-1,并且可滑动地布置在外壳118的纵向室120中。标记物部署触发器130在手柄112的外壳118的外部可接近。标记物部署触发器130包括内套筒130-1和外致动器130-2。标记物部署触发器130安装到外壳118以便沿着触发器狭槽118-5滑动移动。
图11-14显示了标记物部署触发器130的内套筒130-1和外致动器130-2的运动的各个阶段。在本实施例中,标记物部署触发器130和引入器杆导向块128由第一剪切元件132连接。第一剪切元件132从标记物部署触发器130的内套筒130-1延伸并且驻留在位于引入器杆导向块128中的凹窝134中。
初始地,如图11中所示,标记物部署触发器130的内套筒130-1和外致动器130-2由安装到内套筒130-1的驱动突舌136连接,所述驱动突舌接合形成于外致动器130-2中的驱动狭槽138,使得内套筒130-1和外致动器130-2初始地同时移动。驱动狭槽138由将驱动狭槽138与细长的引入器杆回缩狭槽142分离的面向下唇边140限定。驱动突舌136可以铰接安装(例如通过连接膜)到内套筒130-1。驱动突舌136包括与驱动狭槽138中的唇边140初始地接合的向上延伸突出部136-1。引入器杆回缩弹簧133在轻微的压缩下定位在套管回缩机构116和引入器杆导向块128之间,并且更具体地,定位在套管导向块156和引入器杆导向块128之间。
参考图12,通过朝着手柄112的外壳118的前端118-1滑动标记物部署触发器130的外致动器130-2将标记物部署触发器130致动使得内套筒130-1沿着纵向室120纵向地移动第一剪切元件132以移位引入器杆导向块128,所述引入器杆导向块又沿着套管16的纵向范围28移位标记物引入器杆18以便当到达图12中所示的标记物部署位置122时从套管16的内腔16-4部署组织标记物12。在该阶段,引入器杆回缩弹簧133被压缩。外壳118包括指示线144,使得当内套筒130-1的前缘146与指示线144对准以指示到达了标记物部署位置122时,用户确信组织标记物12完全部署到套管16的远端16-2之外。
而且,如图12中所示,当标记物部署触发器130定位在标记物部署位置122时,驱动突舌136定位在外壳118中的回缩通道148之上。标记物部署触发器130的外致动器130-2朝着手柄112的外壳118的前端118-1的进一步滑动导致形成驱动狭槽138的后缘的唇边140迫使驱动突舌136的突出部136-1向前扭转以向下变形到形成于手柄112的外壳118中的回缩通道148中,由此允许唇边140开始越过驱动突舌136的突出部136-1。在该阶段,引入器杆回缩弹簧133到达了最大压缩。
如图13中所示,标记物部署触发器130的外致动器130-2朝着手柄112的外壳118的前端118-1的进一步滑动导致唇边140越过驱动突舌136的向上突出部136-1,由此允许驱动突舌136相对于内套筒130-1恢复它的初始几何形状,由此向上移动到回缩通道148之外。当外致动器130-2的前缘150与内套筒130-1的指示线152对准时发生该动作。在该阶段,引入器杆回缩弹簧133开始解压缩。因此,部署机构114的一部分,例如部署机构114的内套筒130-1,外致动器130-2,驱动突舌136,唇边140,和回缩通道148,也用作标记物引入器杆18的引入器杆回缩机构153。
如图14中所示,随着驱动突舌136的向上突出部136-1从回缩通道148完全释放并且驱动突舌136的向上突出部136-1定位在引入器杆回缩狭槽142中,引入器杆回缩弹簧133的解压缩迫使引入器杆导向块128朝着外壳118的后端118-2移动(参见图10),并且接下来转而标记物引入器杆18和内套筒130-1朝着它们的初始位置返回,如图10和11中所示。由引入器杆回缩弹簧133提供的弹簧力可以被选择,例如使得,内套筒130-1与外壳118的端壁118-6的撞击导致第一剪切元件132在横截面尺寸减小的区域132-1剪切,由此便于在套管16初始回缩之前将标记物引入器杆18完全回缩到纵向室120中。
备选地,由引入器杆回缩弹簧133提供的弹簧力可以被选择,例如使得内套筒130-1与外壳118的端壁118-6的撞击在套管16初始回缩之前在标记物引入器杆18的部分回缩之后停止标记物引入器杆18回缩到纵向室120中。
而且,如图14中所示,在该阶段标记物部署触发器130的外致动器130-2不再连接到内套筒130-1。因此,防止了通过致动标记物部署触发器130的外致动器130-2而随后延伸标记物引入器杆18,由此使标记物输送装置110只可用于一次性组织标记物部署。
也再次关于图14和15参考图10,套管回缩机构116安装到手柄112的外壳118并且被配置为当套管回缩机构116由用户致动时便于套管16完全回缩到手柄112的外壳118的纵向室120中,这将最有可能在组织标记物12的部署之后发生。图15显示了套管回缩机构116,其中标记物引入器杆18处于标记物部署位置122。套管回缩机构116被配置为在套管16和标记物引入器杆18完全回缩到纵向室120中之后防止套管16和标记物引入器杆18延伸到手柄112的外壳118的纵向室120之外,因此便于标记物输送装置110的安全处置,并且减少在标记物输送装置10的使用后对医务人员或患者的意外扎针的忧虑。
套管回缩机构116包括回缩触发器154,套管导向块156,第二剪切元件158,和套管回缩弹簧160。回缩触发器154可以采用例如通过侧壁118-3中的孔118-7在外壳118的外部可接近的按钮的形式。套管导向块156附连到套管16的近端16-1。套管导向块156可滑动地布置在外壳118的纵向室120中。在本实施例中,第二剪切元件158形成为回缩触发器154的延伸部。
回缩触发器154和套管导向块156由驻留在位于套管导向块156中的凹窝162中的第二剪切元件158连接,因此保持套管导向块156相对于手柄112的外壳118静止。套管回缩弹簧160位于外壳118的前端118-1和套管导向块156之间,其中在回缩触发器154的致动之前套管回缩弹簧160处于压缩状态,因此提供作用于套管导向块156的预负荷。
回缩触发器154的致动导致套管16完全回缩到手柄112的外壳118的纵向室120中。更具体地,如图15中所示,初始地,第二剪切元件158的横截面尺寸减小的区域158-1由侧壁118-3支撑,由此在横截面尺寸减小的区域158-1提供附加支撑。回缩触发器154的致动(按压)径向地移位第二剪切元件158,导致第二剪切元件158的横截面尺寸减小的区域158-1通过外壳118的侧壁118-3进入纵向室120,使得第二剪切元件158的横截面尺寸减小的区域158-1不再由侧壁118-3支撑,并且由此由套管回缩弹簧160施加的弹簧力克服第二剪切元件158的横截面尺寸减小的区域158-1的剪切阻力。第二剪切元件158的剪切导致套管回缩弹簧160从所示的压缩状态释放以迫使套管导向块156朝着外壳118的后端118-2移动以完成套管16到手柄112的外壳118的纵向室120中的完全回缩。
在标记物引入器杆18部分回缩的情况下,或者在回缩触发器154的致动之前用户未执行先前所述的标记物引入器杆回缩到手柄112的外壳118的纵向室120中的情况下(如图15中所示),套管回缩弹簧160的继续解压缩导致套管导向块156撞击引入器杆导向块128以剪切第一剪切元件132,由此便于套管16和标记物引入器杆18完全同时回缩到手柄112的外壳118的纵向室120中。
当套管16和标记物引入器杆18都完全包含在手柄112的外壳118的纵向室120中时回缩过程完成。
尽管关于至少一个实施例描述了本发明,但是本发明可以在本公开内容的精神和范围内进一步进行修改。所以本申请旨在涵盖使用它的一般原理的本发明的任何变化、使用或适用。此外,本申请旨在涵盖从本公开内容变化的属于本发明所属领域中的已知或常规实践范围内和属于附带权利要求的范围内的。
Claims (44)
1.一种被配置用于部署组织标记物的标记物输送装置,包括:
具有室的手柄;
套管,其被配置用于保持所述组织标记物以便部署,所述套管具有围绕内腔的侧壁,所述内腔沿着所述套管的纵向范围延伸,所述套管具有由狭槽阵列形成的挠性部分,所述狭槽阵列具有通过所述套管的所述侧壁延伸到所述内腔的多个外周狭槽,所述多个外周狭槽被间隔开以沿着所述套管的纵向范围基本平行,从而便于在所述套管的所述挠性部分处的挠曲;
标记物引入器杆,其能移动地布置在所述套管的所述内腔中,所述标记物引入器杆具有致动端和标记物部署端,以及对应于所述套管的所述挠性部分的挠性区域;
部署机构,其安装到所述手柄并且被配置为当致动所述部署机构时使所述标记物引入器杆移位以部署所述组织标记物,以及
回缩机构,其安装到所述手柄并且被配置为当致动所述回缩机构时便于所述套管和所述标记物引入器杆都完全回缩到所述手柄的外壳的所述室中;
其中所述部署机构包括:
附连到所述标记物引入器杆的所述致动端的引入器杆导向块,所述引入器杆导向块能滑动地布置在所述手柄的外壳的所述室中;
第一剪切元件;以及
在所述外壳的外部能接近的标记物部署触发器,所述标记物部署触发器由第一剪切元件连接到所述引入器杆导向块,其中所述标记物部署触发器的致动导致第一剪切元件使所述标记物引入器杆移位以便沿着所述套管的纵向范围移动所述标记物引入器杆,从而从所述套管的所述内腔部署所述组织标记物。
2.根据权利要求1所述的标记物输送装置,其中所述多个外周狭槽被配置为便于在所述套管的所述挠性部分处沿着单一预定平面的挠曲。
3.根据权利要求1所述的标记物输送装置,其中所述部署机构被配置为将所述标记物输送装置限制为用于标记物部署的一次性使用。
4.根据权利要求1所述的标记物输送装置,其中所述回缩机构被配置为在所述套管和所述标记物引入器杆完全回缩到所述室中之后防止所述套管和所述标记物引入器杆延伸到所述室之外。
5.一种被配置用于部署组织标记物的标记物输送装置,包括:
手柄,其被配置为由用户抓握;
套管,其具有近端和远端,所述近端联接到所述手柄,所述套管是基本刚性的并且具有围绕内腔的侧壁,所述内腔沿着所述套管的纵向范围延伸,所述套管具有由狭槽阵列形成的挠性部分,所述狭槽阵列具有通过所述套管的所述侧壁延伸到所述内腔的多个外周狭槽,所述多个外周狭槽被间隔开以沿着所述套管的纵向范围基本平行,从而便于在所述套管的所述挠性部分处的挠曲;以及
标记物引入器杆,其能移动地布置在所述套管的所述内腔中以实现从所述套管的所述远端部署所述组织标记物,所述标记物引入器杆具有致动端和标记物部署端,以及对应于所述套管的所述挠性部分的挠性区域;
其中所述手柄包括外壳,所述外壳具有前端和后端以及位于所述前端和所述后端之间的室,并且所述外壳具有通向所述室以用于接收所述套管的孔,并且所述外壳包括安装到所述外壳的部署机构,所述部署机构被配置为当所述部署机构由用户致动时使所述标记物引入器杆移位以用于部署所述组织标记物;并且
其中所述部署机构包括:
附连到所述标记物引入器杆的所述致动端的引入器杆导向块,所述引入器杆导向块能滑动地布置在所述外壳的所述室中;
第一剪切元件;以及
在所述外壳的外部能接近的标记物部署触发器,所述标记物部署触发器由第一剪切元件连接到所述引入器杆导向块,其中所述标记物部署触发器的致动导致第一剪切元件使所述标记物引入器杆移位以便沿着所述套管的纵向范围移动所述标记物引入器杆,从而从所述套管的所述内腔部署所述组织标记物。
6.根据权利要求5所述的标记物输送装置,其中所述套管的所述挠性部分离所述套管的所述远端比离所述套管的所述近端更近。
7.根据权利要求5所述的标记物输送装置,其中所述多个外周狭槽被配置为便于在所述套管的所述挠性部分处沿着单一预定平面的挠曲。
8.根据权利要求5所述的标记物输送装置,其中所述多个外周狭槽包括具有第一周向范围的第一组外周狭槽和具有第二周向范围的第二组外周狭槽。
9.根据权利要求8所述的标记物输送装置,其中所述第一周向范围相对于所述第二周向范围在周向上错开。
10.根据权利要求5所述的标记物输送装置,其中所述狭槽阵列包括连接所述多个外周狭槽的至少一部分的轴向狭槽。
11.根据权利要求5所述的标记物输送装置,其中所述套管由金属材料形成。
12.根据权利要求11所述的标记物输送装置,其中所述金属材料是不锈钢、镍钛诺、镍铬合金和钛中的一种。
13.根据权利要求5所述的标记物输送装置,其中所述标记物引入器杆的所述挠性区域形成为挠性金属元件。
14.根据权利要求5所述的标记物输送装置,其中所述标记物引入器杆的所述挠性区域形成为挠性塑料元件,并且所述标记物引入器杆的剩余部分由金属和塑料中的至少一种形成。
15.根据权利要求5所述的标记物输送装置,其中所述外壳还包括安装到所述外壳的回缩机构,所述回缩机构被配置为当所述回缩机构由用户致动时便于所述套管和所述标记物引入器杆都完全回缩到所述手柄的所述外壳的所述室中。
16.根据权利要求5所述的标记物输送装置,其中所述外壳还包括:
在所述外壳的外部能接近的回缩触发器;
第二剪切元件;
附连到所述套管的近端的套管导向块,所述套管导向块能滑动地布置在所述外壳的所述室中,所述回缩触发器由第二剪切元件连接到所述套管导向块以保持所述套管导向块相对于所述手柄的所述外壳静止;以及
位于所述外壳的前端和所述套管导向块之间的弹簧,在致动所述回缩触发器之前所述弹簧处于压缩状态以提供作用在所述套管导向块上的预负荷。
17.根据权利要求16所述的标记物输送装置,其中所述回缩触发器的致动导致所述套管和所述标记物引入器杆都完全回缩到所述手柄的所述外壳的所述室中。
18.根据权利要求16所述的标记物输送装置,其中所述回缩触发器的致动导致第二剪切元件剪切,使得所述弹簧从所述压缩状态释放以迫使所述套管导向块朝着所述外壳的后端移动以便开始所述套管的初始回缩,并且其中所述弹簧的继续解压缩导致所述套管导向块撞击所述引入器杆导向块以剪切第一剪切元件,由此开始所述套管和所述标记物引入器杆到所述手柄的所述外壳的所述室中的同时回缩。
19.根据权利要求18所述的标记物输送装置,其中在所述套管和所述标记物引入器杆都完全包含在所述手柄的所述外壳的所述室中之后,结束所述套管和所述标记物引入器杆到所述手柄中的同时回缩。
20.根据权利要求16所述的标记物输送装置,其中间隔装置定位在所述引入器杆导向块和所述套管导向块之间,所述间隔装置具有沿着纵向范围的长度,使得当所述引入器杆导向块定位在标记物部署位置中时,所述套管导向块与所述引入器杆导向块能操作地接触,从而当所述回缩触发器被致动时第一剪切元件和第二剪切元件同时被剪切,因此所述套管和所述标记物引入器杆完全同时回缩到所述外壳的所述室中。
21.根据权利要求16所述的标记物输送装置,还包括锁定机构以在所述组织标记物被部署之后将所述标记物部署触发器锁定在标记物部署位置中。
22.根据权利要求16所述的标记物输送装置,其中:
所述标记物部署触发器包括第一锁定元件,并且所述外壳包括第二锁定元件,并且
其中当所述标记物部署触发器定位在标记物部署位置中时,所述第一锁定元件永久地接合所述第二锁定元件。
23.根据权利要求22所述的标记物输送装置,其中所述第一锁定元件和所述第二锁定元件中的一个是锁定通道,并且所述第一锁定元件和所述第二锁定元件中的另一个是弹簧加载插入元件,当所述标记物部署触发器定位在标记物部署位置中时,所述弹簧加载插入元件接合所述锁定通道。
24.一种被配置用于部署组织标记物的标记物输送装置,包括:
手柄,其被配置为由用户抓握,所述手柄包括外壳,所述外壳具有前端和后端以及位于所述前端和所述后端之间的室,并且所述外壳具有从所述室通向所述手柄的外部的孔;
套管,其具有近端、远端和沿着所述套管的纵向范围在所述近端和所述远端之间延伸的内腔,所述套管定位在所述手柄中使得所述套管通过所述孔能回缩地延伸超出所述外壳的前端;
标记物引入器杆,其能移动地布置在所述套管的所述内腔中以实现从所述套管的远端部署所述组织标记物,所述标记物引入器杆具有致动端和标记物部署端;
安装到所述外壳的部署机构,所述部署机构联接到所述标记物引入器杆的所述致动端,所述部署机构被配置为当致动所述部署机构时使所述标记物引入器杆移位以部署所述组织标记物,以及
安装到所述外壳的回缩机构,所述回缩机构联接到所述套管的近端,所述回缩机构被配置为当致动所述回缩机构时便于所述套管和所述标记物引入器杆都完全回缩到所述手柄的所述外壳的所述室中,
其中所述部署机构包括:
附连到所述标记物引入器杆的所述致动端的引入器杆导向块,所述引入器杆导向块能滑动地布置在所述外壳的所述室中;
第一剪切元件;以及
在所述外壳的外部能接近的标记物部署触发器,所述标记物部署触发器由第一剪切元件连接到所述引入器杆导向块,其中所述标记物部署触发器的致动导致第一剪切元件使所述标记物引入器杆移位以便沿着所述套管的纵向范围移动所述标记物引入器杆,从而从所述套管的所述内腔部署所述组织标记物。
25.根据权利要求24所述的标记物输送装置,其中:
所述外壳包括延伸通过所述外壳的侧壁的触发器狭槽,
所述标记物部署触发器安装到所述外壳以用于沿着所述触发器狭槽从初始位置滑动移动到标记物部署位置,
所述标记物部署触发器包括第一锁定元件,并且所述外壳包括第二锁定元件,并且
当所述标记物部署触发器定位在标记物部署位置中时,所述第一锁定元件永久地接合所述第二锁定元件。
26.根据权利要求25所述的标记物输送装置,其中所述第一锁定元件和所述第二锁定元件中的一个是锁定通道,并且所述第一锁定元件和所述第二锁定元件中的另一个是弹簧加载插入元件,当所述标记物部署触发器定位在所述标记物部署位置中时,所述弹簧加载插入元件接合所述锁定通道。
27.根据权利要求24所述的标记物输送装置,其中所述回缩机构包括:
在所述外壳的外部能接近的回缩触发器;
第二剪切元件;
附连到所述套管的近端的套管导向块,所述套管导向块能滑动地布置在所述外壳的所述室中,所述回缩触发器由所述第二剪切元件连接到所述套管导向块以保持所述套管导向块相对于所述手柄的所述外壳静止;以及
位于所述外壳的前端和所述套管导向块之间的弹簧,所述弹簧在致动所述回缩触发器之前处于压缩状态以提供作用在所述套管导向块上的预负荷。
28.根据权利要求27所述的标记物输送装置,其中所述回缩触发器的致动导致所述套管和所述标记物引入器杆都完全回缩到所述手柄的所述外壳的所述室中。
29.根据权利要求27所述的标记物输送装置,其中所述回缩触发器的致动导致第二剪切元件剪切,使得所述弹簧从压缩状态释放以迫使所述套管导向块朝着所述外壳的后端移动以便开始所述套管的初始回缩,并且其中所述弹簧的继续解压缩导致所述套管导向块撞击所述引入器杆导向块以剪切第一剪切元件,由此开始所述套管和所述标记物引入器杆到所述手柄的所述外壳的所述室中的同时回缩。
30.根据权利要求29所述的标记物输送装置,其中在所述套管和所述标记物引入器杆都完全包含在所述手柄的所述外壳的所述室中之后,结束所述套管和所述标记物引入器杆到所述手柄中的同时回缩。
31.根据权利要求27所述的标记物输送装置,其中间隔装置定位在所述引入器杆导向块和所述套管导向块之间,所述间隔装置具有沿着纵向范围的长度,使得当所述引入器杆导向块定位在标记物部署位置中时,所述套管导向块与所述引入器杆导向块能操作地接触,从而当所述回缩触发器被致动时所述第一剪切元件和所述第二剪切元件同时被剪切,因此所述套管和所述标记物引入器杆完全同时回缩到所述外壳的所述室中。
32.根据权利要求24所述的标记物输送装置,其中:
所述套管具有由狭槽阵列形成的挠性部分,所述狭槽阵列具有通过所述套管的侧壁延伸到所述内腔的多个外周狭槽,所述多个外周狭槽被间隔开以沿着所述套管的纵向范围基本平行,从而便于在所述套管的所述挠性部分处的挠曲;并且
所述标记物引入器杆具有对应于所述套管的所述挠性部分的挠性区域。
33.根据权利要求32所述的标记物输送装置,其中所述套管的所述挠性部分离所述套管的所述远端比离所述套管的所述近端更近。
34.根据权利要求32所述的标记物输送装置,其中所述多个外周狭槽被配置为便于在所述套管的所述挠性部分处沿着单一预定平面的挠曲。
35.根据权利要求32所述的标记物输送装置,其中所述多个外周狭槽包括具有第一周向范围的第一组外周狭槽和具有第二周向范围的第二组外周狭槽。
36.根据权利要求35所述的标记物输送装置,其中所述第一周向范围相对于所述第二周向范围在周向上错开。
37.根据权利要求32所述的标记物输送装置,其中所述狭槽阵列包括连接所述多个外周狭槽的至少一部分的轴向狭槽。
38.根据权利要求32所述的标记物输送装置,其中所述套管由金属材料形成,并且至少所述标记物引入器杆的所述挠性区域形成为挠性金属元件。
39.根据权利要求32所述的标记物输送装置,其中所述套管由金属材料形成,并且至少所述标记物引入器杆的所述挠性区域形成为挠性塑料元件。
40.根据权利要求24所述的标记物输送装置,其中所述回缩机构包括被配置用于回缩所述标记物引入器杆的第一回缩机构和被配置用于回缩所述套管的第二回缩机构,其中所述标记物引入器杆的初始回缩在所述套管的回缩之前发生。
41.根据权利要求24所述的标记物输送装置,其中所述回缩机构包括被配置用于回缩所述标记物引入器杆的第一回缩机构和被配置用于回缩所述套管的第二回缩机构,其中所述标记物引入器杆的完全回缩在所述套管的回缩之前发生。
42.根据权利要求24所述的标记物输送装置,其中所述部署机构还包括:
第一弹簧,其接合地位于所述引入器杆导向块和附连到所述套管的近端的套管导向块之间;
其中所述标记物部署触发器到第一位置的致动导致所述第一剪切元件使所述标记物引入器杆移位以沿着所述套管的纵向范围移动所述标记物引入器杆,从而从所述套管的所述内腔部署所述组织标记物并且同时压缩所述第一弹簧,并且所述标记物部署触发器到不同于第一位置的第二位置的进一步致动使第一弹簧释放以便解压缩,从而将所述标记物引入器杆回缩到所述手柄的所述外壳的所述室中。
43.根据权利要求42所述的标记物输送装置,其中所述第一弹簧的解压缩导致第一剪切元件的剪切,以及所述标记物引入器杆完全回缩到所述手柄的所述外壳的所述室中。
44.根据权利要求42所述的标记物输送装置,所述回缩机构包括:
所述套管导向块,所述套管导向块能滑动地布置在所述外壳的所述室中;
安装到所述外壳的回缩触发器,所述回缩触发器联接到所述套管导向块;以及
第二弹簧,其接合地位于所述外壳的前端和所述套管导向块之间,在致动所述回缩触发器之前所述第二弹簧处于压缩状态以提供作用在所述套管导向块上的预负荷,
其中所述回缩触发器的致动导致所述第二弹簧的解压缩,所述第二弹簧的所述解压缩使得所述套管完全回缩到所述手柄的所述外壳的所述室中。
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CN102256660A (zh) | 2011-11-23 |
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AU2008365906B2 (en) | 2015-01-22 |
JP5453453B2 (ja) | 2014-03-26 |
EP3005971A3 (en) | 2016-07-20 |
EP4215147A2 (en) | 2023-07-26 |
BRPI0823399A2 (pt) | 2015-06-16 |
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